FDA has published a 20-page report, summarized in a Health Affairs article, on South Korea's response to COVID from the perspective of diagnostic testing. The article is authored by the FDA's director for all medical devices, Jeff Shuren, and the director for diagnostics, Tim Stenzel.
Key points include:
- History of Korean investments and public-private partnerships
- Supporting financial risk for test manufacturers
- Tests were validated in central locations sponsored by the K-CDC
- A national testing strategy was rolled out (plan)
- Networks of testing sites developed (bricks and mortar)
- The quarantine violation rate for positive individuals is estimated to be very very low.